AccessGUDID - DEVICE: BMET-11-2, 2% LIDOCAINE (M9797424601M1)

GUDID

Device Identifier (DI) Information

Brand Name: BMET-11-2, 2% LIDOCAINE
Version or Model: 11GAUGE x 4"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMET-11-2
Company Name: RANFAC CORP.

Primary DI Number: M9797424601M1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: BMET-11-2, 2% LIDOCAINE PN 74246-01M

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983187	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
Length: 4 Inch
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: 2d711cc6-b15b-408c-b5fe-a9fdc454bd48
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 31, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M9797424601M9	10	M9797424601M1		In Commercial Distribution	Case

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

[?]

Phone: 5085884400
Email: info@ranfac.com

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