AccessGUDID - DEVICE: RAPHAEL (00841732108042)

GUDID

Device Identifier (DI) Information

Brand Name: RAPHAEL
Version or Model: 015.7081
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CTL Medical Corporation

Primary DI Number: 00841732108042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080138504 *Terms of Use

Device Description: Hex Driver with Handle, 5.0

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?
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, Fixation, Spinal Intervertebral Body
KWP	Appliance, Fixation, Spinal Interlaminal
MNH	Orthosis, Spondylolisthesis Spinal Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132365	000

Device Exempt from Premarket Submission: No 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: b19011bd-ce6f-4940-a48f-df0b435987cf
Public Version Date: July 11, 2024
Public Version Number: 3
DI Record Publish Date: September 15, 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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1 (214) 545-5820
Email: schedule@ctlamedica.com

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

FDA TOOLS & RESOURCES