Model: 2161
DI: 00199536901179
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Bouffant Cap, SPP, White, 24"
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f79e6547-99f2-4461-ade2-5c935bddeacc
Distribution Status:
In Commercial Distribution
DUNS Number:
119522714
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
30199536901170
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00199536901179
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00199536901179
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CASE
Item #3 - Device ID:
50199536901174
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
5
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30199536901170
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 32297
Name: Surgical cap, single-use
Definition:
A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
FDA Product Codes
FYF
Cap, Surgical