FDA.report

ArcRoyal

Primary DI
06931918180482
Brand
ArcRoyal
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model 10-519001
Device description
Yellow Needle Counter, Foam Block/Magnet, Blade Remover Feature, 20CT, 40CP_Non-sterilize_100ea/cs
Published
2021-02-27
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
true

Related Records

Contact Domains

Product Codes

CodeName
GABNEEDLE, SUTURING, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16931918180489PrimaryGS10
06931918180482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693191818048916931918180489
06931918180482069319181804826931918180482

GMDN Terms

TermDefinition
Sharp surgical instrument counting tray/pad, single-useA device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+86057383617385link_dong@gri-metc.com

Regulatory Flags

DUNS number
679894738
Device count
100
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
false

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26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

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