FDA UDI In Commercial Distribution 🇺🇸 United States

Greenwald Surgical Company, Inc.

DI: 10801334001476 · Model: 51100-15 · GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Greenwald Surgical Company, Inc.
Primary DI
10801334001476
Version / Model
51100-15
Catalog Number
U403
Company Name
GRACE MANUFACTURING, INC.
Labeler DUNS
607903382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
3
Public Version Date
2023-07-25
Public Version Status
Update
Public Device Record Key
f51ee131-227a-40f7-a553-2bf03bd2288c

Device Description

Stamey Needle, 15 degree angled tip

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Liquid Chemical", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
KOA Surgical Instruments, G-U, Manual (And Accessories)

GMDN Terms

Code Name
47441 Transvaginal needle, surgical

Identifiers

Type ID
Primary 10801334001476

Device Sizes

Type Value Unit Text
Angle 15 degree
Length 6.375 Inch