AccessGUDID - DEVICE: NA (10887587075679)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: SD03.501.800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD03501800
Company Name: Synthes GmbH

Primary DI Number: 10887587075679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: RIB REDUCTION ROD FOR 90 DEGREE SCREWDRIVER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48025	Orthopaedic bone-fragment manipulator, reusable	A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae94c8ad-116b-43bf-9ef0-b469eb256d6d
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: June 19, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES