AccessGUDID - DEVICE: SYNOVO HIP COMPONENTS (00814193025708)

GUDID

Device Identifier (DI) Information

Brand Name: SYNOVO HIP COMPONENTS
Version or Model: 01-03-0042
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-03-0042
Company Name: Synovo Production

Primary DI Number: 00814193025708
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061486164 *Terms of Use

Device Description: HIP FEMORAL RESURFACING CUP - 42.5MM

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?
33717	Resurfacing metallic hip prosthesis	An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXA	Prosthesis, Hip, Femoral, Resurfacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904870	000

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 42.5 Millimeter

Device Record Status

Public Device Record Key: e899edb6-c144-4b37-81b8-3490cb9e300d
Public Version Date: March 14, 2024
Public Version Number: 2
DI Record Publish Date: March 02, 2024

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

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES