FDA.reportPublic FDA data

Crilewood Needle Holder 150mm

Primary DI
05060411983021
Brand
Crilewood Needle Holder 150mm
Company
DTR MEDICAL LIMITED
Model
CNH2015
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060411983038PackageGS120In Commercial Distribution
05060411983021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060411983038050604119830385060411983038
05060411983021050604119830215060411983021

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry / Keep out of Sunlight

Regulatory Flags#

DUNS number
424066509
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerASN20182026-06-10
05060212050687Bruenings Tongue Depressor, 190mmBRU20012026-06-10
05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10
05060212051738Clamp Cover White (Med) 120mmCCW20412026-06-10
05060212051745Clamp Cover Blue (Large) 120mmCCB20512026-06-10
05060212052094Tischler Cervical Biopsy PunchCBT10012026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchCBT1001B2026-06-10
05060212052339Cusco Specula Metal SmallCMM200S2026-06-10
05060212052346Cusco Specula Metal MediumCMM200M2026-06-10
05060212052360Cusco Specula Metal LargeCMM200L2026-06-10
05060212052629Cawthorne Hook 1.5mm 90 degree blackCTH2901-D2026-06-10
05060212052636Cawthorne Straight Point blackCTP2001-D2026-06-10
05060212053466Barron Suction Handle (3Fg)BSH20032026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060411982963Birks Tying Forceps 110mm, 5mm Platform with 0.3mm TipsDTR MEDICAL LIMITEDHCF2026-06-10
05060411984486De Bakey Needle Holder 180mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411985032Castroviejo Needle Holder with Lock 145mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411986961Barraquer Needle Holder 120mm, Curved 12mm Jaws, non lockingDTR MEDICAL LIMITEDHCF2026-06-10
00198506091285ELMED INCORPORATEDELMED INCORPORATEDHCF2026-06-09
00192896123441Barraquer Anis Needle HolderSONTEC INSTRUMENTS, INC.HCF2026-06-02
00198506090653ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-12
00198506090486ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-05
14026704937131WECKTELEFLEX INCORPORATEDHCF2026-04-24
00840343727451Gen2SURGIX MEDICAL LLCHCF2026-04-22
04058749044812NAFehling Instruments GmbH & Co. KGHCF2026-04-22
00198506090035ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-08
00198506089893ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-02
04058749121087NAFehling Instruments GmbH & Co. KGHCF2026-03-05
00198506088223ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-27
00198506088162ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506088179ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506087660ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00198506087776ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00848657077989AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00848657077996AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00850012846512C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
10850012846519C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
04058749118711NAFehling Instruments GmbH & Co. KGHCF2025-12-08
00190776413446MillenniumAvalign Technologies, Inc.HCF2025-10-09
00198506085963ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-03
00198506072956ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082214ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082221ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
G453521053112M0PEAK MEDICALPeak Medical Distribution Inc.HCF2025-10-01