FDA UDI In Commercial Distribution 🇺🇸 United States

Greenwald Surgical Company, Inc.

DI: 10801334011901 · Model: 51200-00 · 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
10801334011901
Version / Model
51200-00
Catalog Number
U530
Company Name
GRACE MANUFACTURING, INC.
Labeler DUNS
607903382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-31
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
130f579a-a389-41fd-8601-bf13804f2c68

Device Description

Stamey Dorsal Vein Apical Retractor. Stainless steel throughout. Handle flange provides secure control and cephaled retraction. Retractor blades provide a wide space on both sides of the dorsal vein complex for placing a controlling suture.

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
Moist Heat or Steam Sterilization

Product Codes

Code Name
FGN Retractor, Non-Self-Retaining

GMDN Terms

Code Name
13393 Vessel retractor

Identifiers

Type ID
Primary 10801334011901