FDA.report

AESCULAP

Primary DI
04038653337378
Brand
AESCULAP
Company
Aesculap AG
Model
BN507R
Catalog number
BN507R
Device description
MICHEL SUTURE CLIP 7.5X1.75MM
Published
2020-04-17
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
FZQCLIP, REMOVABLE (SKIN)

Product Code Classifications

CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653002214PrimaryGS10
04038653337378Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653002214040386530022144038653002214
04038653337378040386533373784038653337378

GMDN Terms

TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

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
100
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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04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
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04038653038251AESCULAPDP512RDP512R2020-06-17

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00842331160783Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
00842331163944Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
00653405037234REFLEXConmed CorporationFZQ2021-10-14
00653405037258REFLEXConmed CorporationFZQ2021-10-14
30653405047098CONMED REFLEXConmed CorporationFZQ2021-10-14
10850010207091BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
10653405036920REFLEXConmed CorporationFZQ2020-11-13
10653405036951REFLEXConmed CorporationFZQ2020-11-13
10653405036982REFLEXConmed CorporationFZQ2020-11-13
10653405037019REFLEXConmed CorporationFZQ2020-11-13
10653405048381REFLEXConmed CorporationFZQ2020-11-13
10653405050599REFLEXConmed CorporationFZQ2020-11-13
10653405050605REFLEXConmed CorporationFZQ2020-11-13
10653405050896REFLEXConmed CorporationFZQ2020-11-13
04046826314606MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314613MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314620MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314637MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314644MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314651MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314668MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
10850010207176BandGrip® Micro-Anchor® ClosureBANDGRIP INC.FZQ2020-07-27
04038653337385AESCULAPAesculap AGFZQ2020-04-17
04038653337392AESCULAPAesculap AGFZQ2020-04-17
04038653337408AESCULAPAesculap AGFZQ2020-04-17
04038653337415AESCULAPAesculap AGFZQ2020-04-17
04038653337422AESCULAPAesculap AGFZQ2020-04-17
04038653337439AESCULAPAesculap AGFZQ2020-04-17
10850010207138BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2020-03-25
30850010207071BandGrip® Micro-Anchor® ClosureBANDGRIP INC.FZQ2020-03-24