Device
TITANIUM CLIP FOR TEM with bracket, PACK=10x 6 PCS, for clip applicator 8840.7621, sterile, for single use
Manufacturer
Richard Wolf GmbH
Model: 4840764 Catalog: 4840764 DI: 04055207048788 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Description
TITANIUM CLIP FOR TEM with bracket, PACK=10x 6 PCS, for clip applicator 8840.7621, sterile, for single use
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 2af0158c-17e0-4864-849f-c87092018e05
Distribution Status: In Commercial Distribution
DUNS Number: 315304071
Device Count: 60
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 04055207051054
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 04055207048788
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 45612
Name: Soft-tissue/mesh anchor, non-bioabsorbable
Definition:
A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.
FDA Product Codes
FJL
Resectoscope
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value: 5
Item #1 - Storage Handling High - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value: 30
Item #1 - Storage Handling Type: Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value: 0
Item #2 - Storage Handling High - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value: 70
Item #2 - Storage Handling Type: Storage Environment Humidity