FDA.report

Racord Two Retraction Cord 10/2

Primary DI
00310866000596
Brand
Racord Two Retraction Cord 10/2
Company
PASCAL COMPANY, INC.
Model
07820
Catalog number
07820
Device description
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, size 10/2
Published
2019-01-24
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

Contact Domains

Product Codes

CodeName
MVLCord, Retraction

Product Code Classifications

CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00310866000596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866000596003108660005963108660005960310866000596

GMDN Terms

TermDefinition
Gingival retraction cord, medicatedA medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
8004268051pascal@pascaldental.com

Regulatory Flags

DUNS number
009260217
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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