AccessGUDID - DEVICE: NA (10886982237590)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 511.610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 511610
Company Name: Synthes GmbH

Primary DI Number: 10886982237590
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: AIR OSCILLATOR

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?
37876	Surgical power tool system handpiece, rotary, pneumatic	A hand-held, pneumatically-powered device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. The device may be cannulated to enable use of a guidewire and may be of the micro or macro design. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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: ac49e97d-f6f7-41a3-9b17-dbedf24ca4ef
Public Version Date: April 25, 2022
Public Version Number: 4
DI Record Publish Date: December 31, 2016

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
HIBCC	H67951161008

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: Yes
DM DI Number: 07611819110793
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

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