AccessGUDID - DEVICE: Arthrex® (00888867348769)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-1250XS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR-1250XS
Company Name: ARTHREX, INC.

Primary DI Number: 00888867348769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: Ø2.4mm x 120mm DRILL TIP GUIDE PIN

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:	Yes
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?
65729	Multiple progressive systemic sclerosis-associated antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple antibodies associated with progressive systemic sclerosis in a clinical specimen. The assayed autoimmune antibodies may be directed at scleroderma-70 (Scl-70), polymyositis-scleroderma (PM-Scl), centromere proteins (e.g., CENPA, CENPB), RNA Polymerase III subunits, fibrillarin, nucleolar transcription factor 1 (NOR-90), Th/To, Ku, platelet-derived growth factor receptor (PDGFR), and/or Ro52 (TRIM21).	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: f73610ea-d2da-4d0e-ae53-e623c52256a0
Public Version Date: March 18, 2024
Public Version Number: 3
DI Record Publish Date: December 15, 2020

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: No
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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)934-4404
Email: complaints@arthrex.com

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

FDA TOOLS & RESOURCES