FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653159994
Brand
AESCULAP
Company
Aesculap AG
Model
FD231R
Catalog number
FD231R
Device description
"BARRAQUER Micro Needle Holder, curved, 4 3/4"", (120 mm), smooth, spring type, round handle, without ratchet, suture 9/0 - 11/0, non-sterile, reusable"
Published
2020-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653159994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653159994040386531599944038653159994

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
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
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621879Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621886Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621893Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621909Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621916Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621923Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621930Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621947Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621954Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621961Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621978Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
G45313110753150PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-05-06
G4254202900My MedicalMy Medical Store LLCFHQ2026-05-04
G4254203160My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209120My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209140My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209170My MedicalMy Medical Store LLCFHQ2026-02-17
G45313110845130PEAK MEDICALPeak Medical Distribution Inc.FHQ2023-07-03
G25004025180Tungsten Carbide Debakey Needle Holder 18cmN S SURGICAL COMPANYFHQ2023-01-27