FDA.report

AESCULAP

Primary DI
04046955076604
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG098R
Catalog number
MG098R
Device description
PRICE MUSCLE BIOPSY CLAMP 15MMW DBL-PRNG
Published
2020-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HFBFORCEPS, BIOPSY, GYNECOLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046955076604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046955076604040469550766044046955076604

GMDN Terms

TermDefinition
Muscle biopsy clampA sterile manual gripping device designed to secure muscle tissue in order to obtain a biopsy sample. It is used to hold a muscle fibre specimen in a longitudinal position to help preserve the original orientation of the fibres, from the sampling stage through analysis of the tissue. It will typically be designed so that, with the in situ sample, it can fit into an automated histological processing/analysing machine. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
082594540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04046955741380AESCULAPFK962NBFK962NB2025-08-17

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