FDA.report

PRO-CHAIN

Primary DI
00810152821152
Brand
PRO-CHAIN
Company
Ortho Pro Dent LLC
Model
M05-910
Device description
Elastomeric ligature chain Continuous - Black 15 ft / spool
Published
2024-11-04
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
true

Related Records

Contact Domains

Product Codes

CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810152821152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152821152008101528211528101528211520810152821152

GMDN Terms

TermDefinition
Orthodontic archwire/bracket ligatureA device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
941-402-6504edward@orthoprodent.com

Regulatory Flags

DUNS number
085719913
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810152825556Orthodontic PlierOP-1002024-11-06
00810152825563Orthodontic PlierOP-1022024-11-06
00810152825570Orthodontic PlierOP-1032024-11-06
00810152825587Orthodontic PlierOP-1042024-11-06
00810152825594Orthodontic PlierOP-1052024-11-06
00810152825600Orthodontic PlierOP-1062024-11-06
00810152825617Orthodontic PlierOP-1072024-11-06
00810152825624Orthodontic PlierOP-1082024-11-06
00810152825631Orthodontic PlierOP-1092024-11-06
00810152825648Orthodontic PlierOP-1102024-11-06
00810152825655Orthodontic PlierOP-1112024-11-06
00810152825662Orthodontic PlierOP-1122024-11-06
00810152825679Orthodontic PlierOP-1132024-11-06
00810152825686Orthodontic PlierOP-1142024-11-06
00810152825693Orthodontic PlierOP-1152024-11-06
00810152825709Orthodontic PlierOP-1162024-11-06
00810152825716Orthodontic PlierOP-1172024-11-06
00810152825723Orthodontic PlierOP-1182024-11-06
00810152825730Orthodontic PlierOP-1192024-11-06
00810152825747Orthodontic PlierOP-1202024-11-06

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