FDA.report

Medline Industries, Inc.

Primary DI
40888277583604
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1302
Catalog number
DYNDA1302
Device description
CAUTERY PENCIL
Published
2016-11-07
Public version status
Update
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
OFFCentral venous catheter tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40888277583604PackageGS150In Commercial Distribution
10888277583603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088827758360440888277583604
1088827758360310888277583603

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). 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
true
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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