FDA UDI In Commercial Distribution 🇺🇸 United States

Weitlaner Retractor 14cm Blunt

DI: G25009050130 · Model: 09-050-13 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Weitlaner Retractor 14cm Blunt
Primary DI
G25009050130
Version / Model
09-050-13
Catalog Number
09-050-13
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-28
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
53d1fc47-11cc-4943-a90f-4e2577b44fde

Device Description

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Ultraviolet Light"]

Product Codes

Code Name
GAD Retractor

GMDN Terms

Code Name
45918 Hand-held surgical retractor, reusable

Identifiers

Type ID
Primary G25009050130

Device Sizes

Type Value Unit Text
Length 14 Centimeter