AccessGUDID - DEVICE: Disc Prep (10889981103552)

GUDID

Device Identifier (DI) Information

Brand Name: Disc Prep
Version or Model: 06-40-0408
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06-40-0408
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981103552
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: O'Brien Currette, 18" OAL, 9" Handle

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?
48729	Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple serotypes of Poliovirus (PV1-PV3) in a clinical specimen, using a complement fixation test (CFT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTF	CURETTE

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
Device Size Text, specify: 18", 9"

Device Record Status

Public Device Record Key: f7d3145e-e3a0-427a-86d0-b4f2a1fcdfcc
Public Version Date: December 30, 2024
Public Version Number: 3
DI Record Publish Date: May 02, 2016