Device
DSSA-35-R
Manufacturer
Sinolinks Medical Innovation Co., Ltd.
Model: DSSA-35-R DI: 06946480584057 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 778d3bec-4c7e-4684-be95-a4f8ae08230c
Distribution Status: In Commercial Distribution
DUNS Number: 528192598
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 06946480584057
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35884
Name: Skin stapler/staple, non-bioabsorbable
Definition:
A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.
FDA Product Codes
QQS
Stapler, Skin