AccessGUDID - DEVICE: NA (10886982274229)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 03.404.001S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03404001S
Company Name: Synthes GmbH

Primary DI Number: 10886982274229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: RIA 2 REAMING KIT 520MM STERILE

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:	Yes
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?
47951	Surgical power tool drive-shaft seal	A small sterile device designed as an external seal that is placed on the drive shaft of a rotary cutting tool (e.g., an orthopaedic reamer) that is attached to and driven by a surgical power tool in order to prevent the backflow of fluid (i.e., blood and rinsing fluid) penetrating the drive mechanisms of the power tool. It is made of synthetic material (e.g., silicone) and is available in a variety of shapes and sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	REAMER
HRX	Arthroscope

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: b0f81edf-69fb-4e8c-a62b-77fcb8b74a45
Public Version Date: January 16, 2023
Public Version Number: 3
DI Record Publish Date: November 22, 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: 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)255-2500
Email: xx@xx.xx

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