FDA.report

PEAK MEDICAL

Primary DI
G45313110796140
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
131-1079.614
Device description
Mayo-Hegar Needle Holder - Straight jaws w/TC inserts, Stainless Steel, 12" (30.5cm)
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications

CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G45313110796140PrimaryHIBCC0

GMDN Terms

TermDefinition
Suturing 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078393632
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
G453335200112L0PEAK MEDICAL3352001-12L2026-01-05
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05
G453333553810PEAK MEDICAL3335-53812026-01-02
G453CD351170PEAK MEDICALCD3-51172025-12-07
G453CD433180PEAK MEDICALCD4-33182025-12-07
G453CD455160PEAK MEDICALCD4-55162025-12-07
G453CD467140PEAK MEDICALCD4-67142025-12-07
G453335243001H0PEAK MEDICAL3352430-01H2025-08-20
G453335243002H0PEAK MEDICAL3352430-02H2025-08-20
G453335243003H0PEAK MEDICAL3352430-03H2025-08-20
G4533352105310PEAK MEDICAL335210-5312025-08-13
G453PM57246210PEAK MEDICALPM57246-212025-07-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0NEEDLE HOLDER MAYO-HEGAR 7" LEFT HAND TCW.H. Holden, Inc.FHQ2026-01-05
D9283011450NEEDLE HOLDER MAYO-HEGAR 8" / 20CM TCW.H. Holden, Inc.FHQ2026-01-05
D9283011510NEEDLE HOLDER OLSEN-HEGAR 4 1/2" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011570NEEDLE HOLDER OLSEN-HEGAR 7 1/4" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
D928301173OS0NEEDLE HOLDER MINI-RYDER 6" SM OFF SET HANDLEW.H. Holden, Inc.FHQ2026-01-05
D92830117470NEEDLE HOLDER MINI-RYDER 7" TC NEW PATTERNW.H. Holden, Inc.FHQ2026-01-05
D928301174D0NEEDLE HOLDER MINI-RYDER 7" DELICATE, TC SERRATEDW.H. Holden, Inc.FHQ2026-01-05
B382S56621000Surgical DirectSurgical Direct, Inc.FHQ2025-12-29