FDA.report

MEDLINE RENEWAL

Primary DI
20888277368337
Brand
MEDLINE RENEWAL
Company
MEDLINE INDUSTRIES, INC.
Model
3622R
Catalog number
3622R
Device description
3622 SUPER-ATRAUMATIC GRABBER CONTROL T
Published
2023-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277368337PackageGS110In Commercial Distribution
20888277384245PackageGS110In Commercial Distribution
10888277368330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827736833720888277368337
2088827738424520888277384245
1088827736833010888277368330

GMDN Terms

TermDefinition
Rigid endoscopic scissors, single-useA sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false

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10197344039890MEDLINEHNY22100HNY221002024-10-11
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10197344099771MEDLINEAVT0665AVT06652025-03-10

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