AccessGUDID - DEVICE: Continuum (00850039803048)

GUDID

Device Identifier (DI) Information

Brand Name: Continuum
Version or Model: PS-01-1412S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pressio, Inc

Primary DI Number: 00850039803048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084706556 *Terms of Use

Device Description: ACDF IMPLANT KIT - 14X12MM STRAIGHT

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
58235	Memory-alloy orthopaedic fixation plate	A non-sterile implantable device made of a shape memory alloy (SMA) [e.g., nickel-titanium alloy (Nitinol)] designed for the fixation of a bone fracture without the use of screws or wires or other holding devices. It typically consists of a cylindrical or conical plate with a pair or pairs of gripping arms to bridge and stabilize the fracture gap of a bone, e.g., long bones, rib and sternum, and shield the site from stress as the bone heals. Compression is achieved by the temperature-controlled properties of the SMA. It is available in a variety of sizes and is typically surgically removed after the healing process. It is a single-use device intended to be sterilized prior to use.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHQ	Anterior Staple As Supplemental Fixation For Fusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200301	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32b3c7de-0f13-4443-8580-b0b995139b97
Public Version Date: May 09, 2023
Public Version Number: 1
DI Record Publish Date: May 01, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8666484665
Email: INFO@PRESSIOSPINE.COM

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