FDA.report

HNM MEDICAL

Primary DI
00842962110690
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-13-8112
Catalog number
HNM-1-13-8112
Device description
WACHENFELDT SUTURE CLIP, 12MM
Published
2023-03-30
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
HBOClip, Scalp

Product Code Classifications

CodeDeviceSpecialtyClass
HBOClip, ScalpNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842962110690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962110690008429621106908429621106900842962110690

GMDN Terms

TermDefinition
Scalp clip forcepsA hand-held, manually-operated, surgical instrument used to manually apply and remove haemostatic scalp clips (reusable or single-use) from the scalp during or after a surgical intervention on the cranium/scalp. It is typically a scissors-like device with ring handles, and may or may not be self-retaining. The working end of the device will typically have dedicated grasping blades that are profiled/designed to accommodate a compatible scalp clip. The device is available in various sizes and is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

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

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10841742149124HNM MEDICALHBI-BA-100HBI-BA-1002024-08-30
10841742148929HNM MEDICALHNM-17506HNM-175062024-05-14
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