Prometheus Clavicle System Bone Plate

GUDID 08806390897600

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390897600
NIH Device Record Key89723fb9-0f71-46b2-95f5-66f63e437e55
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometheus Clavicle System Bone Plate
Version Model NumberPRO-10260
Company DUNS688811603
Company NameJeil Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806390897600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


[08806390897600]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

On-Brand Devices [Prometheus Clavicle System Bone Plate]

08806390897679PRO-10264
08806390897662PRO-10262
08806390897655PRO-10251
08806390897648PRO-10249
08806390897631PRO-10261
08806390897624PRO-10248
08806390897617PRO-10263
08806390897600PRO-10260
08806390897594PRO-10250
08806390897587PRO-10247
08806390897570PRO-10259
08806390897563PRO-10246
08806390897556PRO-10258
08806390897549PRO-10245
08806390897532PRO-10270
08806390897525PRO-10257
08806390897518PRO-10269
08806390897501PRO-10256
08806390897495PRO-10268
08806390897488PRO-10255
08806390897471PRO-10267
08806390897464PRO-10254
08806390897457PRO-10266
08806390897440PRO-10253
08806390897433PRO-10265
08806390897426PRO-10252
08806390896979PRO-10286
08806390896962PRO-10290
08806390896955PRO-10294
08806390896948PRO-10274
08806390896931PRO-10278
08806390896924PRO-10282
08806390896917PRO-10285
08806390896900PRO-10289
08806390896894PRO-10293
08806390896887PRO-10273
08806390896870PRO-10277
08806390896863PRO-10281
08806390896856PRO-10284
08806390896849PRO-10288
08806390896832PRO-10292
08806390896825PRO-10272
08806390896818PRO-10276
08806390896801PRO-10280
08806390896795PRO-10283
08806390896788PRO-10287
08806390896771PRO-10291
08806390896764PRO-10271
08806390896757PRO-10275
08806390896740PRO-10279

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