FDA.report

AESCULAP

Primary DI
04038653155682
Brand
AESCULAP
Company
Aesculap AG
Model
FB151R
Catalog number
FB151R
Device description
Vascular Spatula, curved, 8 1/2", (215 mm), blunt, width: 3 mm, non-sterile, reusable
Published
2020-06-17
Public version status
Update
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
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653155682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653155682040386531556824038653155682

GMDN Terms

TermDefinition
Vessel depressorA hand-held manual surgical instrument designed to displace tissue to facilitate examination of the surrounding area during vessel surgery. It is typically a double-ended device, that can be of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working ends slightly angled to improve tissue manipulation and visibility. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
true
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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04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
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04046964526213ECCOSGB068RGB068R2020-04-24
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