FDA.report

AESCULAP

Primary DI
04038653085279
Brand
AESCULAP
Company
Aesculap AG
Model
FF005R
Catalog number
FF005R
Device description
SCALP HEMOSTASIS CLIP
Published
2016-09-23
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653085279PrimaryGS10
04038653339723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653085279040386530852794038653085279
04038653339723040386533397234038653339723

GMDN Terms

TermDefinition
Scalp haemostasis clip, single-useA small, manually-operated and applied surgical device used to stop bleeding from the scalp during surgery on the cranium. It is is usually applied to the scalp using the fingers or a dedicated pair of scalp clip forceps, and consists of two blades that are joined at a midpoint. It is typically made of plastic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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
10
DM exempt
true
Premarket exempt
false
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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04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
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