FDA.reportPublic FDA data

"NEEDLE HOLDER MAYO-HEGAR 7"" LEFT HAND TC"

Primary DI
D928301140LH0
Brand
"NEEDLE HOLDER MAYO-HEGAR 7"" LEFT HAND TC"
Company
W.H. Holden, Inc.
Model
30-1140LH
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D928301140LH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183854322
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9282000201SUL0SMITH SAGGITAL SPLITTER-MOD20-0020-1-SUL2026-05-27
D928105406HFDLC0STAHR TUNNEL RETRACTOR HF D/E DLC10-5406HFDLC2026-03-18
D928105535DLC0"""OH"" ZYGOMA RETRACTOR DLC"10-5535DLC2026-03-18
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN40-0400-1CH2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN40-0400-2CH2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE40-0400CH2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE40-0400HD2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE40-0400HF2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE40-0435RD2026-03-18
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28