FDA.report

Meta Clip-P Applier Plus(OMAPLLA)

Primary DI
08806387895633
Brand
Meta Clip-P Applier Plus(OMAPLLA)
Company
Meta Biomed Co., Ltd.
Model
9563
Device description
Meta Clip-P Applier Plus are indicated for use as delivery or remover devices for the clips of Meta Biomed Co., Ltd. Both applier and remover are made of stainless steel.
Published
2022-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDOApplier, Surgical, Clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806387895633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806387895633088063878956338806387895633

GMDN Terms

TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688322841
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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08806387814719MX 04-4014712025-08-26
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08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26
08806387814757MX 06-3014752025-08-26
08806387814764MX 06-3514762025-08-26
08806387814771MX 06-4014772025-08-26
08806387814788MG 02-15 LM14782025-08-26
08806387814795MG 02-20 LM14792025-08-26

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