FDA.reportPublic FDA data

HNM Medical

Primary DI
00842962113646
Brand
HNM Medical
Company
HNM STAINLESS, LLC.
Model
HNM-1-22-0063
Catalog number
HNM-1-22-0063
Device description
DAVIS BRAIN SPATULA, 5/8"X7"
Published
2023-04-17
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

Product Codes#

Code, Name table
CodeName
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962113646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962113646008429621136468429621136460842962113646

GMDN Terms#

Term, Definition table
TermDefinition
Brain spatulaA hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
806754185
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841742143672HNM MEDICALHNM-1-09-8310SHNM-1-09-8310S2025-05-16
10841742149476HNM MEDICALHNM-1-09-8308SHNM-1-09-8308S2025-05-16
10841742149483HNM MEDICALHNM-1-09-8312SHNM-1-09-8312S2025-05-16
00841742149585HNM MedicalHNM-1-57-2097HNM-1-57-20972025-04-18
00841742149592HNM MedicalHNM-1-57-2099HNM-1-57-20992025-04-18
00841742149608HNM MedicalHNM-1-57-2098HNM-1-57-20982025-04-18
10841742149353HNM MedicalHNM-45-002HNM-45-0022025-01-27
10841742149377HNM MEDICALHNM-1-62-2210SHNM-1-62-2210S2025-01-27
10841742149384HNM MEDICALHNM-1-62-2215SHNM-1-62-2215S2025-01-27
10841742149391HNM MEDICALHNM-1-62-2220SHNM-1-62-2220S2025-01-27
00841742149233HNM MedicalHNM-1-550-1524HNM-1-550-15242024-11-18
00841742148939HNM MedicalHNM-250-000-011HNM-250-000-0112024-11-08
00841742148946HNM MedicalHNM-250-000-012HNM-250-000-0122024-11-08
00841742148953HNM MedicalHNM-250-000-013HNM-250-000-0132024-11-08
00841742149219HNM MedicalHNM-250-000-014HNM-250-000-0142024-11-08
10841742149124HNM MEDICALHBI-BA-100HBI-BA-1002024-08-30
10841742148929HNM MEDICALHNM-17506HNM-175062024-05-14
00841742148854HNM MedicalHNM-250-000-001HNM-250-000-0012024-04-01
00841742148861HNM MedicalHNM-250-000-002HNM-250-000-0022024-04-01
00841742148878HNM MedicalHNM-250-000-003HNM-250-000-0032024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19
B382SD915039120Surgical DirectSurgical Direct, Inc.GAF2025-05-19
B382SD9150471110Surgical DirectSurgical Direct, Inc.GAF2025-05-19
04049047034964GimmiGimmi GmbHGAF2025-05-06
B382SD1552400Surgical DirectSurgical Direct, Inc.GAF2025-05-05
B382SD1552420Surgical DirectSurgical Direct, Inc.GAF2025-05-05
B382SD1552440Surgical DirectSurgical Direct, Inc.GAF2025-05-05
B356KF411240American MedicalsAmerican MedicalsGAF2025-04-18
00840343725761GEN2SURGIX MEDICAL LLCGAF2025-02-25
00840343725778GEN2SURGIX MEDICAL LLCGAF2025-02-25
00840343725785GEN2SURGIX MEDICAL LLCGAF2025-02-25
00810158214101PRINCETONPrinceton Medical Group, Inc.GAF2025-01-21