FDA.report

Endocator

Primary DI
10810138822705
Brand
Endocator
Company
Endo Direct LLC
Model
ENDOCATOR
Published
2023-07-16
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

Product Codes

CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810138822705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081013882270510810138822705

GMDN Terms

TermDefinition
Light meterA battery-powered, hand-held, electronic instrument intended to be used to measure and establish the quantity or strength of light (illuminance and/or luminance). Also known as a luxmeter, an illuminometer, or an illuminance photometer, this GMDN code includes those devices using photometric means to measure, e.g., daylight, artificial light (i.e., light produced by electricity), screen luminance, levels of night-light or light in the dark.

Sterilization Methods

Method

Regulatory Flags

DUNS number
125216703
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company

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10810138823382ProShape HT-Assorted PackSample2026-03-16
10810138823399ProShape One Assorted PackSample2026-03-16
10810138823405Proshape Cyclone Asst PackSample2026-03-16
10810138823412Proshape Conserve Asst PackSample2026-03-16
10810138823276RC MixEDRCMIX2025-03-03
10810138823269ProShape Orifice BarrierPSOS172025-01-13
10810138823245ProShape Path Size 13 21mmPSPATH212024-11-14
10810138823252ProShape Path Size 13 25mmPSPATH252024-11-14
10810138823238EndoCeramic Root Repair MaterialECRRM2024-10-21
10810138822736ProShape Gutta Percha F1PSGPF12024-08-02
10810138822743ProShape Gutta Percha F2PSGPF22024-08-02
10810138822750ProShape Gutta Percha F3PSGPF32024-08-02
10810138822767ProShape Gutta Percha F4PSGPF42024-08-02
10810138822774ProShape Gutta Percha F5PSGPF52024-08-02
10810138822781ProShape Paper Points F1PSPPF12024-08-02
10810138822798ProShape Paper Points F2PSPPF22024-08-02
10810138822804ProShape Paper Points F3PSPPF32024-08-02
10810138822811ProShape Paper Points F4PSPPF42024-08-02
10810138822828ProShape Paper Points F5PSPPF52024-08-02
10810138822835ProShape One Gutta Percha SmallPSOGPSM2024-08-02

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00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
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09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
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00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05
00850229007027StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05
00850229007034StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05
00850229007041StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05
00850229007102StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05
00850229007126LumiStatAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05